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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name filler, bone void, osteoinduction (w/o human growth factor)
510(k) Number K052735
Device Name ALLOCRAFT DBM
Applicant
LIFECELL CORP.
555 13TH STREET, NW
WASHINGTON,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
LIFECELL CORP.
555 13TH STREET, NW
WASHINGTON,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number888.3045
Classification Product Code
MBP  
Subsequent Product Code
MQV  
Date Received09/30/2005
Decision Date 12/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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